This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy

Secondary Outcome Measures:

Proportion of patients with a favorable overall response

Enrollment:

100

Study Start Date:

April 2004

Study Completion Date:

October 2006

Primary Completion Date:

October 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: caspofungin acetate

Duration of Treatment: 28-90 days

Other Name: MK0991

Drug: Comparator: AmBisome

Duration of Treatment: 28-90 days

Eligibility

Ages Eligible for Study:

2 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who are 2 through 17 years of age

Absolute Neutrophil Count (ANC) is below 500/microliter

Have persistent fever (at least 4 days) despite antibiotic therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082537